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DESCRIPTION:In the EU\, all companies are required to provide risk managem
 ent plans (RMPs) for every new product\, whether generic products or new 
 chemical entities\, and these RMPs must also be modified and updated thro
 ughout the lifetime of a medicine. This intensive one-day course will pro
 vide you with an invaluable overview of writing and maintaining RMPs\, wi
 th practical advice to ensure you achieve regulatory compliance. You will
  discuss best practice for using the EU templates and risk minimisation t
 ools to enhance the benefit/risk of your product.\n\nThe programme has be
 en fully revised to cover the latest updates and new requirements\, inclu
 ding amendments made to the previous template.\n\nBenefits of attending:\
 n\n\nGain an overview of ICH and EU RMPs – their production and ongoing m
 aintenance\nClarify the documentation to be supplied to regulators and th
 e process for RMPs\nLearn what happened in the EU RMP update and explore 
 the new requirements\nDiscuss the EU templates and their completion – gen
 eric and innovator products\nUnderstand the relationship between RMPs\, p
 ost-authorisation safety and efficacy studies\, safety reviews and PBRERs
 \nDiscuss the RMP and risk minimisation follow-up\n
DTEND:20210128T163000
DTSTAMP:20260512T213554Z
DTSTART:20210128T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:In the EU\, all companies are required to provide risk management 
 plans (RMPs) for every new product\, whether generic products or new chem
 ical entit...
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